Figure 1. Cautionary Advisory Label Number 13
Ideally, oral dose forms of medicines such as tablets and capsules should be administered in their original, unaltered state. However many people, particularly older patients and children, may find it difficult to swallow them. In some cases patients are unable to take medication orally at all, requiring administration via an enteral feeding tube.
Altering solid dosage forms by crushing or splitting tablets, or by opening capsules, is a tempting and practical option, but not always an appropriate one. Problems may include;
- Loss of efficacy
- Increased risk of toxicity
- Taste and texture issues
- Reduction in stability, and
- Work Health and Safety (WHS) concerns.
In the event of an adverse clinical outcome, there may also be legal implications for health professionals involved in altering a commercial product contrary to the manufacturer’s product licence. The excellent new reference Australian Don’t Rush to Crush Handbook is an invaluable guide to the options available for people unable to swallow oral medications.
Assessment of swallowing ability
A person’s ability to swallow food and orally administered medicines can be affected by;
- Physical difficulties – dysphagia (secondary to stroke, Parkinson’s disease, multiple sclerosis, Motor Neurone Disease [MND], reduced level of consciousness, dry mouth).
- Physiological factors – deteriorating cognition (e.g. dementia), inability or aversion to swallowing tablets.
Dysphagia can be a particular problem in older people, due to weakening of the muscles involved in swallowing, a reduction in salivary gland function, and the increased likelihood that they will have developed a medical condition affecting the swallowing process.
Review by a speech pathologist should be considered in both the hospital and aged care setting for assessment of chewing and swallowing. If the inability to swallow relates to a particular time of the day, just changing medicine administration times may be all that is needed to resolve the problem.
Review of the medication regimen
A patient’s recently developed swallowing problem should be seen as a good opportunity to completely review their medication regimen, with a view to finding suitable alternative formulations such as liquids, powders for suspension, patches, or suppositories. If these are not an option, it may become necessary to consider alternative drugs, or cease some medication altogether.
If dry mouth (xerostomia) is a contributory factor, identify any possible drug related causes such as antihistamines, tricyclics antidepressants, selective serotonin reuptake inhibitors, tiotropium/ipratropium, oxybutynin, and opioids. Consider the possibility of ceasing any medications at this stage, or using a suitable alternative tablet formulation, patch, or liquid.
Consider the following options;
- An alternate drug in the same class may have a prolonged duration of action, but still
be an immediate release formulation that can be crushed, e.g. amlodipine in place of felodipine SR.
- An alternate form of the same drug may be suitable to crush or be otherwise modified to enable administration, e.g. isosorbide dinitrate instead of mononitrate SR, or morphine sulphate as Kapanol® instead of MS Contin®. There may also be a chewable or soluble form available, e.g. sodium valproate chewable tablets.
- A liquid if available, e.g. sodium valproate (Epilim® Syrup), phenytoin (Dilantin Paediatric®), or oxycodone (OxyNorm® Liquid). It may be necessary to adjust the dose, or dosing interval, to achieve the same effect. Monitor closely.
- A soluble tablet. This may be an option, e.g. soluble paracetamol, but needs to be discussed with a pharmacist as many soluble tablets are high in sodium content and may be inappropriate for some medical conditions such as hypertension.
Alteration of an oral formulation
If there are no suitable alternatives available commercially, then it may be necessary to consider crushing, or otherwise modifying, the existing dosage form. In many cases, this is quite acceptable, but it is still important to consider the risks, including;
- Reduced effectiveness of the medication
- Increased risk of toxicity
- Possible risks to healthcare workers or carers preparing the medication
- Making the drug so unpalatable that adherence is reduced, and
- Reducing the stability of the drug.
A pharmacist should be consulted for advice before crushing is initiated, and the product information should be checked carefully. Consult specialised texts, if available (see references). Pharmacists may need to contact the manufacturer directly.
Categories of medications which should not be altered
Understanding the reason, and method of treatment of tablets and capsules helps us to know when and why they should only be swallowed whole.
Altered absorption or release
Many of these products can be identified by postscripts to the product name such as CR, MR, XR, XL, CD, or SR which implies a treatment to modify the rate of release of the medication, such as ‘CR’ meaning Controlled Release. They are designed to release the medicine over an extended period (12-24 hours). Crushing can result in a large bolus dose, high peaks, and toxicity. For example crushing verapamil SR tablets increases the risk of hypotension and bradycardia, whereas Kapanol® or MS Mono® capsules may be opened if the pellets are swallowed without chewing to prevent high plasma peaks and the risk of opioid toxicity, alternating with long periods of inadequate analgesia between doses.
Enteric coatings cover the whole tablet, or the pellets within a capsule, to protect the medicine from gastric acidity, and allow dissolution in the intestine. It improves bioavailability of medicines that are unstable in an acid environment, such as omeprazole, or reduce gastrointestinal side effects as with non steroidal anti-inflammatories.
Film coating on tablets protects the contents from atmospheric light and moisture, which may cause them to break down rapidly. Nifedipine, for example, is very light sensitive, where aspirin is hygroscopic. Do not remove non-enteric coated tablets from packaging until immediately before use, as described on the ‘Cautionary Advisory Label’ (Figure 1) applied to the packaging.
Failure to reach site of action
Enteric coatings can also control the specific site of release of medicines within the gastrointestinal tract. Crushing can result in loss of efficacy and/or increase of side effects. Mesalazine, for example, is intended to act in the lower small intestine or colon, depending on the brand. Crushing can increase the risk of kidney damage and reduce efficacy.
Local irritant effect
Some coatings are to protect the oesophagus and stomach from a directly irritant effect of the medicine, as seen with bisphosphonates and tetracyclines. The bisphosphonate (alendronate) can cause severe upper gastrointestinal irritation and/or ulceration. If tablets must be crushed, ensure plenty of water is taken to wash away the particles.
Work Health and Safety
Highly potent and toxic medicines including cytotoxics, teratogens, contact irritants, and hormones can be dangerous to the handler. Finely crushed particles may be inhaled, so specific safety precautions should be followed to minimise risks. Finasteride presents a risk to male foetuses (Australian category X). Pregnant women, or women of child-bearing age, should not handle crushed or broken tablets. Cyclophosphamide and methotrexate (which may also be used for arthritis) are cytotoxic. Isotretinoin is used to treat acne, but is teratogenic; and chlorpromazine is an irritant which causes contact dermatitis.
Drugs like ibuprofen and quinine have an unpleasant taste, whereas hydroxychloroquine is extremely bitter. Sugar coatings or film coatings may be used to mask the taste or smell of the medicine. While crushing will not change the medicinal benefit, the patient may become distressed by the experience.
- Burridge N, Deidun D, editors for the SHPA Publications Reference Group. Australian don’t rush to crush handbook: therapeutic options for people unable to swallow solid oral medicines. 1st ed. Collingwood: Society of Hospital Pharmacists of Australia; 2011.
- Pharmaceutical Society of Australia. Australian Pharmaceutical Formulary and Handbook APF 22. Canberra: PSA; 2012.
- Department of Health and Ageing. Guiding principles for medication management in residential aged care facilities. Canberra: Commonwealth of Australia; 2012.
- Australian Pharmaceutical Advisory Council. Guidelines for medication management in residential aged care facilities. 3rd ed. Canberra: Commonwealth of Australia; 2002.